Background
Methods
Patients
Treatment
Study evaluations
Statistical analysis
Results
Patient characteristics
No. of patients
| 27 |
Median age [range], years
| 61.4 [47.6 - 74.1] |
Gender
| |
Male | 15 (55.6%) |
Female | 12 (44.4%) |
ECOG performance status score
| |
0 | 5 (18.5%) |
1 | 7 (25.9%) |
2 | 9 (33.3%) |
3 | 3 (11.1%) |
Unknown | 3 (11.1%) |
First line chemotherapy
| |
FOLFIRI.3 alternating with Gemcitabine | 7 (25.9%) |
Gemcitabine | 20 (74.1%) |
Pancreatic tumor location
| |
Head | 14 (51.8%) |
Body | 6 (22.2%) |
Tail | 6 (22.2%) |
Multicentric | 1 (3.7%) |
Metastatic sites
| |
Liver | 20 (74.1%) |
Peritoneum | 8 (29.6%) |
Lung | 6 (22.2%) |
Distant lymph nodes | 2 (7.4%) |
No. of metastatic sites involved
| |
1 | 19 (70.4%) |
2 | 7 (25.9%) |
≥ 3 | 1 (3.7%) |
Baseline CA 19–9 level
| |
≤ 37 UI/ml* | 2 (7.4%) |
> 37 UI/ml | 19 (70.4%) |
Unknown | 6 (22.2%) |
No. of cycle
| |
Mean | 6 |
Median [range] | 4 [1–28] |
Toxicity
No. of Patients (%) | ||||
---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
Hematologic event
| ||||
Neutropenia | 2 (7.4) | 3 (11.1) | 2 (7.4) | 0 (0.0) |
Febrile neutropenia | - | - | 0 (0.0) | 0 (0.0) |
Thrombocytopenia | 12 (44.4) | 1 (3.7) | 3 (11.1) | 0 (0.0) |
Anemia | 10 (37.0) | 5 (18.5) | 2 (7.4) | 0 (0.0) |
Nonhematologic event
| ||||
Asthenia | 7 (25.9) | 11 (40.7) | 4 (14.8) | 0 (0.0) |
Nausea/Vomiting | 10 (37.0) | 6 (22.2) | 0 (0.0) | 0 (0.0) |
Mucitis | 3 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Diarrhea | 6 (22.2) | 4 (14.8) | 0 (0.0) | 0 (0.0) |
Sensory neuropathy | 10 (37.0) | 2 (7.4) | 2 (7.4) | 0 (0.0) |
Tumor response and survival
No. of Patients (%) | |
---|---|
Tumor response
| |
Complete response | 0 (0.0) |
Partial response | 0 (0.0) |
Stable disease | 8 (36.4) |
Progression disease | 14 (63.6) |
Median progression free survival (months) [95% CI]
| 1.7 [1.0 - 2.5] |
Median overall survival (months) [95% CI]
| 4.3 [2.2 - 5.9] |
Prognostic factors
Discussion
Authors | Prospectives Studies | No. of Patients | First-line therapy | Regimen | ECOG Performance status (PS) | ORR | Median TTP | Median OS | Main Toxicities grade 3-4 |
---|---|---|---|---|---|---|---|---|---|
Androulakis N et al., 2005 [18] | Phase II | 18 | Gemcitabine-based, n=18 | oxali 180 mg/m2 q3weeks | PS 0, n=4 PS 1, n=9 PS 2, n=5 | 0% | _ | 3.5 mo | Diarrhoea 5% Vomiting 5% (Neutropenia 0%) |
Tsavaris N et al., 2005 [23] | Phase II | 30 | Gemcitabine, n=30 | oxali 50 mg/m2 D1,Leucovorin 50 mg/m2 D1,5FU 500 mg/m2 D1,q1 week | KPS 100-80%, n=10 KPS 70-50%, n=20 | 23% | 22 wks | 25 wks | Leucopenia 16% Diarrhoea 14% |
Mitry E et al., 2005 [19] | phase II | 18 | Oxaliplatin, n=10 5FU, n=8 | oxaliplatin 130 mg/m2 D1,5FU 1000 mg/m2 D1-D4,q3weeks | PS 0-1, n=4PS 2, n=7 PS > 2, n=4 Unknown, n=3 | 0% | 0.9 m | 1.3 mo | Neutropenia 19% Anemia 25% Asthenia 56% |
Xiong HQ et al., 2008 [20] | Phase II | 41 | _ | oxaliplatin 110–130 mg/m2 D1,capecitabine 1.5-2 g/m2 D1-D14q3week | PS 0, n=4 PS 1, n=16 PS 2, n=8 | 3% | 9.9 wks* | 23 wks | Asthenia 13% Diarrhoea 5% |
Pelzer U et al., 2009 [21] | Phase II | 37 | Gemcitabine, n=37 | oxaliplatin 85 mg/m2 D8, 22 folinic acid 500 mg/m2 D1,8,15,225FU 2600 mg/m2 D1,8,15,22 q6weeks | KPS 90-60%, n=37 | 6% | 12 wks | 22 wks | Nausea/vomiting 11% Diarrhoea 12% |
Novarino A et al., 2009 [22] | Phase II | 23 | Gem alone, n=13 Gem/5FU/cisplatin, n=5 Gem/5FU, n=4 Gem/oxaliplatin, n=1 | oxaliplatin 40 mg/m2 D1,8,15 leucovorin 250 mg/m2 D1,8,15 5FU 500 mg/m2 D1,D8,15 q4weeks | PS 0, n=6 PS 1, n=11 PS 2, n=6 | 0% | 11.6 wks | 17.1 wks | Diarrhoea 9% (Neutropenia 0%) |
Yoo C et al., 2009 [14] | Randomised phase II (versus FOLFIRI3) | 30 | Gem alone, n=2Gem/cap, n=26 Gem/erlotinib, n=2 | oxaliplatin 85 mg/m2 D1 leucovorin 400 mg/m2 D1 5FU 2000 mg/m2 D1,D2 q2weeks | PS 0, n=5 PS 1, n=24 PS 2, n=1 | 7% | 6 wks* | 14.9 wks | Neutropenia 20% Asthenia 14% |
Pelzer U et al., 2011 [8] | Randomised phase III (versus BSC) | 23 | Gemcitabine, n=23 | oxaliplatin 85 mg/m2 D8, 22 folinic acid 200 mg/m2 D1,8,15,22 5FU 2000 mg/m2 D1,8,15,22 q6weeks | KPS 100-90%, n=12 KPS 80-70%, n=11 | _ | _ | 4.82 mo (vs 2.3 mo BSC) | Diarrhoea 9% (Neutropenia 0%) |